Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?

• Sponsor: Shaare Zedek Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01075334
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

Many cases of male infertility are poorly understood and regarded as unexplained. Therefore, a etiological treatment for this condition can not be offered in most cases. A beneficial effect on sperm motility was found in trails using antioxidants such as carnitine, zinc and folic acid. However, most studies lacked a sufficient power to detect a significant effect on pregnancy rates. In this study, infertile men with abnormal sperm quality parameters will be randomized to receive either carnitine-based food supplement (Porimore) or folate and Zinc Tablets.

Condition or Disease	Intervention/Treatment	Phase
Male Infertility	Dietary Supplement: Porimore - A Carnitine based food supplement; Dietary Supplement: Zinc and Folate Supplementation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Feb 1, 2010
• Anticipated Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Porimore arm Infertile men will receive 'Porimore' tablets for a period of time in which three intrauterine insemination cycles will be performed.	Dietary Supplement: Porimore - A Carnitine based food supplement; A daily dose of 2 grams L-carnitine, 1 gr acetyl L-carnitine, 500mg Vitamin C, 400 IU vitamin E, 60 mg Q10, 30mg Zinc Picolinate, 500mcg Folic Acid, 200 Mcg Selenium, 100 MCG Vitamin B12.
Active Comparator: Folate and Zinc	Dietary Supplement: Zinc and Folate Supplementation; 500 Mcg Folic acid, 30-60 mg Zinc tablets/ day

Outcome Measures

Primary Outcome Measures

1. Pregnancy Rate [3 Insemination cycles]

   proportion of women becoming pregnancy following treatment with intrauterine insemination

Secondary Outcome Measures

1. Sperm quality parameters [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• infertility

• at least one abnormal sperm quality parameter

• female age < 35

• normal ovarian reserve

Exclusion Criteria:

• known allergy to one of the food additives planned for treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shaare-Zedek IVF and infertility unit	Jerusalem		Israel	91031

Sponsors and Collaborators

• Shaare Zedek Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Isidori AM, Pozza C, Gianfrilli D, Isidori A. Medical treatment to improve sperm quality. Reprod Biomed Online. 2006 Jun;12(6):704-14. Review.

• ClinicalTrials.gov Identifier: NCT01075334
• Other Study ID Numbers: porimore.CTIL
• First Posted: Feb 25, 2010
• Last Update Posted: Feb 25, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: sperm; male infertility; Carnitine; food supplementation; insemination
• Additional relevant MeSH terms: Infertility; Infertility, Male

Study Results

No Results Posted as of Feb 25, 2010